ANDA 213269

TARO PHARMS

FDA Drug Application

Application #213269

Application Sponsors

ANDA 213269

TARO PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;TOPICAL

0.064%;0.005%

0

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-02

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

TARO PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213269
            [companyName] => TARO PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE","activeIngredients":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","strength":"0.064%;0.005%","dosageForm":"SUSPENSION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/02\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-02
        )

)